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Diss Factsheets
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EC number: 682-678-3 | CAS number: 182121-12-6
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- repeated dose toxicity: oral, other
- Type of information:
- other: EFSA/AFC/FCM/1033-Rev. IIA/39815 from May 2007
- Adequacy of study:
- supporting study
- Study period:
- 90-days, repeated dose
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- abstract
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- 16th List of FCM substances
- Author:
- EFSA
- Year:
- 2 007
- Bibliographic source:
- EFSA/AFC/FCM/1033-Rev.IIA/39815 of May 2007
Materials and methods
- Principles of method if other than guideline:
- Review article: 90-day oral toxicity study in rats mentioned
- GLP compliance:
- not specified
Test material
- Specific details on test material used for the study:
- 9,9-Bis(methoxymethyl)fluorene
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
Administration / exposure
- Route of administration:
- oral: unspecified
- Duration of treatment / exposure:
- 90-days
- Frequency of treatment:
- repeated dose
Doses / concentrationsopen allclose all
- Dose / conc.:
- 750 other: mg/kg bw/day (unspecified)
- Remarks:
- maximum dose
- Dose / conc.:
- 250 other: mg/kg bw/day (unspecified)
- Dose / conc.:
- 74 other: mg/kg bw/day (unspecified)
- Remarks:
- minimum dose
- Remarks:
- other doses not mentioned
Examinations
- Observations and examinations performed and frequency:
- no histopathological changes found
at 750 mg/kg bw/day: increase in relative liver weight, changes in clinicla chemistry (ketonuria),
at 250 mg/kg bw/day: changes in clinicla chemistry (ketonuria)
NOEL from this study: 74 mg/kg bw/day
Results and discussion
Results of examinations
- Clinical signs:
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Description (incidence and severity):
- changes in clinicla chemistry (ketonuria) at 750 mg/kg bw/ day and 250 mg/kg bw/day
- Urinalysis findings:
- effects observed, treatment-related
- Description (incidence and severity):
- ketonuria at 750 mg/kg bw/ day and 250 mg/kg bw/day
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- increases in relative liver weights at 750mg/kg bw/day
- Gross pathological findings:
- not specified
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Description (incidence and severity):
- no histopathological findings even at top dose
- Histopathological findings: neoplastic:
- not specified
- Description (incidence and severity):
- no histopathological findings even at top dose
Effect levels
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 74 other: mg/kg bw/day (not specified)
- Based on:
- not specified
- Sex:
- not specified
- Remarks on result:
- other: data from review
Target system / organ toxicity
- Key result
- Critical effects observed:
- yes
- System:
- hepatobiliary
- Organ:
- liver
- Treatment related:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Applicant's summary and conclusion
- Conclusions:
- In this review article a 90-day repeated-dose oral toxicity study in rats is mentioned. At the highest dose of 750 mg/kg bw/day an increases of liver weights were observed. At 750 and 250 mg/kg bw/day changes in clinicla chemistry (kezonuria) occured.
A NOAEL is derived: 74 mg/kg bw/day
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.